Policy For Responding to Allegations of Research Misconduct

I. Introduction

A. General Policy The community of Brown University condemns any form of dishonesty or misconduct in research and accepts responsibility for developing and maintaining the highest standards of intellectual integrity. A climate of intellectual honesty mandates that all scholars have an obligation to conduct research in a manner reflecting these principles.

If it should appear that an incident of academic dishonesty may have occurred in this community, Brown University will act with dispatch and according to Federal regulations and will adhere to the following procedures with regard to instances of alleged misconduct arising out of the performance of scholarly research.

B. Scope This policy and the associated procedures apply to all individuals at Brown University engaged in research. This policy applies to any person paid by, under the control of, or affiliated with the institution, such as scientists, trainees, technicians and other staff members, students, fellows, guest researchers, or collaborators at Brown University. The policy and associated procedures will normally be followed when an allegation of possible research misconduct is received by an institutional official. Particular circumstances in an individual case may dictate variation from the normal procedures when deemed in the best interests of Brown University and/or external sponsors of research. [Any change from the normal procedures also must ensure fair treatment to the subject of the inquiry or investigation. Any significant variation should be approved in advance by the Office of the Vice President for Research of Brown University.

II. Definitions

• Allegation means any written or oral statement of possible research misconduct made to an institutional official. • Complainant means a person who makes an allegation of research misconduct. • Conflict of Interest, as used in this Policy, means the real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships • Evidence means any document, tangible item, or testimony offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact. • Good faith allegation means an allegation made with the honest belief that research misconduct may have occurred. An allegation is not in good faith if it is made with knowing or reckless disregard for facts that would negate the allegation or testimony. • Inquiry means preliminary information gathering and preliminary fact-finding to determine whether an allegation or apparent instance of research misconduct warrants an investigation. • Investigation means the formal development of a factual record and the examination of that record leading to a decision not to make a finding of research misconduct or to a recommendation for a finding of research misconduct which may include a recommendation for other appropriate actions, including administrative actions. • Notice means a written communication served in person, sent by mail or its equivalent to the last known street address, facsimile number or e-mail address of the addressee. • ORI means the Office of Research Integrity, the office within the U.S. Department of Health and Human Services (DHHS) that is responsible for the research misconduct and research integrity issues related to the U.S. Public Health Service supported activities • PHS means the U.S. Public Health Service, an operating component of the DHHS • PHS regulations means the Public Health Service regulation establishing standards for institutional inquiries and investigations into allegations of research misconduct, which is set forth at 42 C.F.R. Part 93, entitled "Public Health Service Policies on Research Misconduct." • PHS support means PHS grants, contracts, or cooperative agreements or applications/proposals for same. • Research Integrity Officer means the institutional official responsible for assessing allegations of research misconduct and determining when such allegations warrant inquiries and for overseeing inquiries and investigations. The Research Integrity Officer is also the institutional official who makes final determinations on allegations of research misconduct and any responsive institutional actions. The Vice President for Research, or his or her designee, will serve as the Research Integrity Officer. • Research misconduct, scientific misconduct, or misconduct in science means fabrication, falsification, plagiarism, or other practices that significantly deviate from those that are commonly accepted within the research community for proposing, conducting, or reviewing research or in reporting research results. It does not include honest error or honest differences in interpretations or judgment of data. • Research record means the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided to an institutional official by a respondent in the course of the research misconduct proceeding. • Respondent means the person against whom an allegation of research misconduct is directed or the person whose actions are the subject of the inquiry or investigation. There can be more than one Respondent in any inquiry or investigation. • Retaliation means any adverse action taken against an individual in response to a good faith allegation of research misconduct, or good faith cooperation with research misconduct proceedings of the University.

III. Rights and Responsibilities

A. Research Integrity Officer The Research Integrity Officer will have primary responsibility for implementation of the procedures set forth in this document. The Research Integrity Officer will be an institutional official who is well qualified to handle the procedural requirements involved and is sensitive to the varied demands made on those who conduct research, those who are accused of misconduct, and those who report apparent misconduct in good faith. The Research Integrity Officer will appoint the inquiry and investigation committees and ensure that necessary and appropriate expertise is secured to carry out a thorough and authoritative evaluation of the relevant evidence in an inquiry or investigation. The Research Integrity Officer will attempt to ensure that confidentiality is maintained. The Research Integrity Officer will assist inquiry and investigation committees and all institutional personnel in complying with these procedures and with applicable standards imposed by government or external funding sources. The Research Integrity Officer is also responsible for securing and maintaining the confidentiality of all documents and evidence. The Research Integrity Officer will report to external sponsors of research, as required by regulation, and will keep these sponsors apprised of any developments during the course of the inquiry or investigation that may affect current or potential funding for the individual(s) under investigation. The Research Integrity Officer will receive the inquiry and/or investigation report and any written comments made by the Respondent or the Complainant on the draft report. The Research Integrity Officer will consult with other officials as appropriate and will determine whether to conduct an investigation, whether misconduct occurred, whether to impose sanctions, or whether to take other appropriate actions [see section X].

B. Complainant The Complainant may have an opportunity to testify before the inquiry and investigation committees, to review portions of the draft inquiry and investigation reports pertinent to his/her allegations or testimony, to be informed of the results of the inquiry and investigation, and to be protected from retaliation. The Complainant is responsible for making allegations in good faith and cooperating, in good faith, with an inquiry or investigation.

C. Respondent The Respondent will be informed of the allegations prior to or when an inquiry is opened and notified in writing of the final determinations and resulting actions. The Respondent may also have the opportunity to be interviewed by and present evidence to the inquiry and investigation committees, to review the draft inquiry and investigation reports, and to have the advice of counsel. The Respondent is responsible for cooperating with the conduct of an inquiry or investigation. If the Respondent is not found to have committed research misconduct, he or she has the right to receive institutional assistance in restoring his or her reputation.

IV. General Policies and Principles

A. Responsibility to Report Misconduct All employees or individuals associated with Brown University should report observed, suspected, or apparent research misconduct to the Research Integrity Officer. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she may call the Research Integrity Officer at (401) 863-7999 to discuss the suspected misconduct informally. If the circumstances described by the individual do not meet the definition of research misconduct, the Research Integrity Officer will refer the individual or allegation to other offices or officials with the responsibility for resolving the problem. At any time, an employee may have confidential discussions and consultations about concerns of possible misconduct with the Research Integrity Officer and will be counseled about appropriate procedures for reporting allegations.

B. Protecting the Complainant The Research Integrity Officer will monitor the treatment of individuals who bring allegations of misconduct or of inadequate institutional response thereto, and those who cooperate in inquiries or investigations. The Research Integrity Officer will make reasonable and practical efforts to counter potential and or actual retaliation against these persons in the terms and conditions of their employment or other status at the institution and will review instances of alleged retaliation for appropriate action. Employees should immediately report any alleged or apparent retaliation to the Research Integrity Officer. Also the institution will protect the privacy of those who report misconduct in good faith to the maximum extent possible. For example, if the Complainant requests anonymity, the institution will make an effort to honor the request during the allegation assessment or inquiry within applicable policies and regulations and state and local laws. The Complainant will be advised that if the matter is referred to an investigation committee and the Complainant's testimony is required, anonymity may no longer be guaranteed. Institutions are required to undertake diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations.

C. Protecting the Respondent Inquiries and investigations will be conducted in a manner that will ensure fair treatment to the Respondent(s) in thoroughly carrying out the inquiry or investigation, and confidentiality to the extent possible without compromising public health and safety. Respondents accused of research misconduct may consult with legal counsel, or a non-lawyer personal advisor (who is not a principal or witness in the case) to seek advice and may bring the counsel or personal advisor to interviews or meetings on the case with approval of the inquiry/investigation committee.

D. Cooperation with Inquiries and Investigations Institutional employees will cooperate with the Research Integrity Officer and other institutional officials in the review of allegations and the conduct of inquiries and investigations. Employees have an obligation to provide relevant evidence of research misconduct to the Research Integrity Officer or other institutional officials officially engaged in an inquiry or investigation.

E. Preliminary Assessment of Allegations Upon receiving an allegation of research misconduct, the Research Integrity Officer will immediately assess the allegation to determine whether it is sufficiently credible and specific so that potential evidence of research misconduct may be identified, whether external sponsors are involved, and whether the allegation falls under the definitions of research misconduct contained in this Policy.

F. Using a Consortium or Other Person for Research Misconduct Proceedings (a) The University may use the services of a consortium or person that the institution reasonably determines to be qualified by practice and experience to conduct research misconduct proceedings. (b) A consortium may be a group of institutions, professional organizations, or mixed groups which will conduct research misconduct proceedings for other institutions. (c) A consortium or person acting on behalf of the University must follow the requirements of this part in conducting research misconduct proceedings.

V. Conducting the Inquiry

A. Initiation and Purpose of the Inquiry Following the preliminary assessment, if the Research Integrity Officer determines that the allegation is sufficiently credible and specific so that potential evidence or research misconduct may be identified and the allegation falls under the definitions of research misconduct contained in this Policy, he or she will initiate the inquiry process. In initiating the inquiry, the Research Integrity Officer should clearly identify the original allegation and any related issues that should be evaluated. The purpose of the inquiry is not to reach a final conclusion about whether misconduct definitely occurred or who was responsible, but is a process of gathering information and initial fact-finding to determine whether an allegation or apparent instance of research misconduct warrants an investigation. An investigation is warranted if there is (1) a reasonable basis for concluding that the allegation falls within the definition of research misconduct, and (2) preliminary information gathering and preliminary fact finding from the inquiry indicates that the allegation may have substance.

B. Maintenance and Custody of the Research Records. To the extent not already done so at the allegation stage, after determining an allegation falls within the definition of research misconduct, the Research Integrity Officer will take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceedings.

C. Appointment of the Inquiry Committee The Research Integrity Officer, in consultation with other institutional officials as appropriate, will appoint an inquiry committee. The inquiry committee should consist of individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry. These individuals may be scientists, subject matter experts, administrators, lawyers, or other qualified persons, and they may be from inside or outside the institution. The Research Integrity Officer will notify the Respondent of the proposed committee membership within 10 days of its appointment. If the Respondent submits a written objection to any appointed member of the inquiry committee or expert, based on bias or conflict of interest, within 5 days, the Research Integrity Officer will determine whether to replace the challenged member or expert with a qualified substitute.

D. Charge to the Committee and the First Meeting The Research Integrity Officer will prepare a written charge for the inquiry committee that describes the allegations and any related issues identified during the allegations assessment and states that the purpose of the inquiry is to make a preliminary evaluation of the evidence and testimony of the Respondent, Complainant, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation as required by this Policy. At the committee's first meeting, the Research Integrity Officer will review the charge with the committee, discuss the allegations, any related issues, and the appropriate procedure for conducting the inquiry. The Research Integrity Officer will assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee. The Research Integrity Officer and institutional counsel will be present or available throughout the inquiry to advise the committee as needed.

E. Inquiry Process The inquiry committee will normally interview the Complainant, the Respondent, and key witnesses as well as examine relevant research records and materials. Then the inquiry committee will evaluate the evidence and testimony obtained during the inquiry. After consultation with the Research Integrity Officer and institutional counsel, as deemed appropriate and necessary, the committee will decide whether there is sufficient evidence of possible research misconduct to recommend that an investigation be conducted. The scope of the inquiry does not, necessarily, include deciding whether misconduct occurred or a full review of all the evidence related to the allegation.

VI. The Inquiry Report

A. Elements of the Inquiry Report A written inquiry report must be prepared that states the name and title of the respondent; the name and title of the committee members and experts, if any; the allegations; external sponsor support; a summary of the inquiry process used; a list of the research records reviewed; summaries of any interviews; a description of the evidence in sufficient detail to demonstrate whether an investigation is recommended by the inquiry committee and whether any other action should be taken if an investigation is not recommended; comments on the report by the respondent and the complainant. Institutional counsel may review the report for legal sufficiency.

B. Comments on the Draft Report by the Respondent and the Complainant The Research Integrity Officer will make available to the Respondent a copy of the draft inquiry report for comment and rebuttal, any comments received will be attached to the report. 1. Confidentiality The Research Integrity Officer may establish reasonable conditions for review to protect the confidentiality of the draft report. 2. Receipt of Comments Within 10 calendar days of their receipt of the draft report, the Complainant and Respondent will provide their comments, if any, to the inquiry committee. Any comments that the Complainant or Respondent submits on the draft report will become part of the final inquiry report and record. Based on the comments, the inquiry committee may revise the report as appropriate.

C. Inquiry Decision and Notification 1. Decision by Research Integrity Officer The Research Integrity Officer will make the determination of whether findings from the inquiry provide sufficient evidence of possible research misconduct to justify conducting an investigation. The inquiry is completed when the Research Integrity Officer makes this determination, which will be made within 60 days of the first meeting of the inquiry committee. Any extension of this period will be based on good cause and recorded in the inquiry file. 2. Notification The Research Integrity Officer will notify both the Respondent and the Complainant in writing of the decision of whether to proceed to an investigation and will remind them of their obligation to cooperate in the event an investigation is opened. In the case of the respondent a copy of the report will be provided. In the case of the complainant, the RIO may provide relevant portions of the report for comment. The Research Integrity Officer will also notify all appropriate institutional officials and, where appropriate, the research sponsor(s) of the decision.

D. Time Limit for Completing the Inquiry Report The inquiry committee will normally complete the inquiry and submit its report in writing to the Research Integrity Officer no more than 60 calendar days following its first meeting, unless the Research Integrity Officer approves an extension for good cause. If the Research Integrity Officer approves an extension, the reason for the extension will be entered into the records of the case and the report. The respondent also will be notified of the extension.

VII. Conducting the Investigation

A. Purpose of the Investigation The purpose of the investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine specifically whether misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are individual instances of possible misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged misconduct involves clinical trails or potential harm to human subjects or the general public or it affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the investigation will be set forth in an investigation report.

B. Sequestration of the Research Records The Research Integrity Officer will immediately sequester any additional pertinent research records that were not previously sequestered during the inquiry. The sequestration should occur before or at the time the Respondent is notified that an investigation has begun. The need for additional sequestration of records may occur for any number of reasons, including the institution's decision to investigate additional allegations not considered during the inquiry stage or the identification of records during the inquiry process that had not been previously secured. The procedures to be followed for sequestration during the investigation are the same procedures that apply during the inquiry.

C. Appointment of the Investigation Committee The Research Integrity Officer, in consultation with other institutional officials as appropriate, will appoint an investigation committee within 30 days after determining that an investigation is warranted. The investigation committee should consist of at least three individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the key principles and witnesses, and conduct the investigation. These individuals may be scientists, administrators, subject matter experts, lawyers, or other qualified persons, and they may be from inside or outside the institution. Individuals appointed to the investigation committee may also have served in the inquiry committee. The Research Integrity Officer will notify the Respondent of the proposed committee membership within 5 days of its appointment. If the Respondent submits a written objection to any appointed member of the investigations committee or expert, the Research Integrity Officer will determine whether to replace the challenged member or expert with a qualified substitute.

D. Charge to the Committee and the First Meeting 1. Charge to the Committee The Research Integrity Officer will define the subject matter of the investigation in a written charge to the committee that describes the allegations and related issues identified during the inquiry; defines research misconduct; and identifies the Respondent(s). The charge will state that the committee is to evaluate the evidence and testimony of the Respondent, Complainant, and key witnesses to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, to what extent, who was responsible, and its seriousness. During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional Respondent(s), the committee will notify the Research Integrity Officer, who will determine whether it is necessary to notify the Respondent of the new subject matter or to provide notice to additional Respondent(s). 2. The First Meeting The Research Integrity Officer, with possible assistance of institutional counsel, will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan. The investigation committee will be provided with a copy of these instructions and, where external sponsors' funding is involved, the sponsors' regulation.

E. Investigation Process The investigation committee will be appointed and the process initiated within 30 days of the completion of the inquiry, if findings from that inquiry provide a sufficient basis for conducting an investigation. The investigation will normally involve examination of all documentation including, but not necessarily limited to, relevant research records, computer files, proposals, manuscripts, publications, correspondence, memoranda, and notes of telephone calls. Whenever possible, the committee should interview the Complainant(s), the Respondent(s), and other individuals who might have information regarding aspects of the allegations. All interviews should be tape recorded, or transcribed. Summaries or transcripts of the interviews should be prepared, provided to the interviewed party for comment or suggested revision, and included as part of the investigatory file.

VIII. The Investigation Report

A. Elements of the Investigation Report The final report will be submitted to the external sponsor, if any, and will: describe the allegations; describe sources of external funding, if any; describe the specific allegations of research misconduct considered in the investigation; describe the policies and procedures under which the investigation was conducted, describe how and from whom information relevant to the investigation was obtained, state the findings, and explain the basis for the findings. The report will include the actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct as well as a description of any sanctions imposed and administrative actions taken by the institution.

B. Comments on the Draft Report 1. Respondent The Research Integrity Officer will provide the Respondent with a copy of the draft investigation report for comment or rebuttal. The Respondent will be allowed 30 days to review and comment on the draft report. The respondent's comments will be attached to the final report. The findings of the final report should take into account the respondent's comments in addition to all the other evidence. 2. Complainant The Research Integrity Officer may provide the Complainant with those portions of the draft investigation report that address the Complainant's role and opinions in the investigation. Where such an opportunity is provided, the Complainant will be allowed 30 days to review and comment on the draft report. The report may be modified, as appropriate, based on the Complainants comments. 3. Institutional Counsel The draft investigation report may be transmitted, as deemed necessary and appropriate, to the institutional counsel for a review of its legal sufficiency. Comments of the counsel will be incorporated into the report as appropriate.

4. Confidentiality In distributing the draft report, or portions thereof, to the Respondent and the Complainant, the Research Integrity Officer will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality. For example, the Research Integrity Officer may request the recipient to sign a confidentiality statement or to come to his or her office to review the report.

C. Institutional Review and Decision Based on a preponderance of the evidence, the Research Integrity Officer will make the final determination whether to accept the investigation report, its findings, and the recommended institutional actions. If this determination varies from that of the investigation committee, the Research Integrity Officer will explain in detail the basis for rendering a decision different from that of the investigation committee in the institution's letter transmitting the report to any external sponsors. The Research Integrity Officer's explanation should be consistent with the federal definitions of research misconduct, the institution's policies and procedures, and the evidence reviewed and analyzed by the investigation committee. The Research Integrity Officer may also return the report to the investigation committee with a request for further fact-finding or analysis. The Research Integrity Officer's determination, together with the investigation committee's report, constitutes the final investigation report for the purposes of external sponsor review. When a final decision on the case has been reached, the Research Integrity Officer will notify both the Respondent and the Complainant in writing. In addition, the Research Integrity Officer will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the Respondent in the work, or other relevant parties should be notified of the outcome of the case. The Research Integrity Officer is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.

D. Transmittal of the Final Investigation Report After comments have been received and the necessary changes have been made to the draft report, the investigation committee should transmit the final report with attachments, including the Respondent's and Complainant's comments, to the Research Integrity Officer. The Research Integrity Officer shall transmit a copy of the Report with attachments to any external sponsors as required.

E. Time Limit for Completing the Investigation Report An investigation should ordinarily be completed within 120 days of its initiation, with the initiation being defined as the first meeting of the investigation committee. This includes conducting the investigation, preparing the report of the findings, making the draft report available to the subject of the investigation for comment, submitting the report to the Research Integrity Officer for approval, and submitting the report to the external sponsor.

IX. Special Requirements for Reporting to ORI in Cases Involving PHS Funding

A. An institution's decision to initiate an investigation must be reported in writing to the Director, ORI, on or before the date the investigation begins. At minimum, the notification should include the name of the person(s) against whom the allegations have been made, the general nature of the allegation as it relates to the PHS definition of research misconduct, and the PHS applications or grant number(s) involved. ORI must also be notified of the final outcome of the investigation and must be provided with a copy of the investigation report. Any significant variations from the provisions of the institutional policies and procedures should be explained in any reports submitted to ORI. B. If an institution plans to terminate an inquiry for any reason other than that an investigation is not warranted or an investigation for any reason without completing all relevant requirements of the PHS regulation, the Research Integrity Officer will submit a report of the planned termination to ORI, including a description of the reasons for the proposed termination. C. If the institution determines that it will not be able to complete the investigation in 120 days, the Research Integrity Officer will submit to ORI a written request for extension that explains the delay, reports on the progress to date, estimates the date of completion of the report, and describes other necessary steps to be taken. If the request is granted, the Research Integrity Officer will file periodic progress reports as requested by the ORI. D. When PHS funding or applications for funding are involved and an admission of research misconduct is made, the Research Integrity Officer will contact ORI for consultation and advice. Normally, the individual making the admission will be asked to sign a statement attesting to the occurrence and extent of misconduct. When the case involves PHS funds, the institution cannot accept an admission of research misconduct as a basis for closing a case or not undertaking and investigation without prior approval from ORI. E. The Research Integrity Officer will notify ORI at any stage of the inquiry or investigation if: 1. there is an immediate health or safety hazard involved, including the immediate need to protect human or animal subjects; or 2. there is an immediate need to protect Federal funds or equipment; or 3. there is an immediate need to protect the interests of the person(s) making the allegations or of the individual(s) who is the subject of the allegations as well as his/her co-investigators and associates, if any; or 4. it is probable that the alleged incident is going to be reported publicly; or 5. the research activities should be suspended; or 6. there is reasonable indication of possible violation of civil or criminal law. In this instance, the institution must inform ORI immediately after obtaining that information.

X. Institutional Administrative Actions

Brown University will take appropriate administrative actions against individuals when an allegation of misconduct has been substantiated. If the Research Integrity Officer determines that the alleged misconduct is substantiated by the findings, he or she will decide on the appropriate actions to be taken. The actions may include:

withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found;

removal of the responsible person from the particular project;

letter of reprimand; special monitoring of future work; probation; suspension;

salary reduction;

initiation of steps leading to possible rank reduction or termination of employment; or restitution of funds as appropriate.

XI. Other Considerations

A. Termination of Institutional Employment or Resignation Prior to Completing Inquiry or Investigation The termination of the respondent's institutional employment, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the misconduct procedures. If the Respondent, without admitting to the misconduct, elects to resign his or her position prior to the initiation of the inquiry, but after an allegation has been made, or during an inquiry or investigation, the inquiry or investigation will proceed. If the Respondent refuses to participate in the process after resignation, the committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the Respondent's failure to cooperate and its effect on the committee's review of all the evidence.

B. Restoration of the Respondent's Reputation If the institution finds no misconduct, after consulting with the Respondent, the Research Integrity Officer will undertake reasonable efforts to restore the Respondent's reputation. Depending on the particular circumstances, the Research Integrity Officer should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in forums in which the allegation of research misconduct was previously publicized, or expunging all reference to the research misconduct from the respondent's personnel file. Any institutional actions to restore the respondent's reputation must first be approved by the Research Integrity Officer.

C. Protection of the Complainant and Others Regardless of whether the institution determines that research misconduct occurred, the Research Integrity Officer will make reasonable efforts to protect Complainants who made allegations of research misconduct in good faith and any individuals who cooperate in good faith with inquiries and investigations of such allegations. Upon completion of an investigation, the Research Integrity Officer will determine, after consulting with the Complainant, what steps, if any, are needed to restore the position or reputation of the Complainant. The Research Integrity Officer is responsible for implementing any such steps. The Research Integrity Officer will also take appropriate steps during the inquiry and investigation to prevent any retaliation against the Complainant.

D. Allegations Not Made in Good Faith If relevant, the Research Integrity Officer will determine whether the Complainant's allegations of research misconduct were made in good faith. If a determination is made that an allegation was not made in good faith, the Research Integrity Officer will determine whether any administrative action should be taken against the Complainant.

E. Interim Administrative Actions Institutional officials will take interim administrative actions, as appropriate, to protect external sponsors' funds and, if Federal funds are involved, ensure that the purposes of the Federal financial assistance are carried out.

XII. Record Retention

After completion of a case and all ensuing related actions, the Research Integrity Officer will prepare a complete file, including the records of any inquiry or investigation and copies of all documents and other materials furnished to the Research Integrity Officer or committees. The Research Integrity Officer will keep the file for seven years beyond completion of the case to permit later assessment of the case. ORI or other authorized DHHS personnel will be given access to the records upon request.